A multicenter randomized phase iii trial of vinorelbine/gemcitabine doublet versus capecitabine monotherapy in anthracycline- and taxane-pretreated women with metastatic breast cancer

Annals of Oncology

Volumn 23, Issue 5, 2012, Pages 1164-1169

  Pallis, A G ^a   Boukovinas, I ^a   Ardavanis, A ^a   Varthalitis, I ^a   Malamos, N ^a   Georgoulias, V ^a   Mavroudis, D ^a  

^a Hellenic Oncology Research Group (HORG)   (Greece)

Author keywords

Capecitabine; Gemcitabine; MBC; Phase III; Pretreated; Vinorelbine

Indexed keywords

CAPECITABINE; GEMCITABINE; NAVELBINE;

ADULT; AGED; ALLERGIC REACTION; ANEMIA; ARTICLE; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EDEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAND FOOT SYNDROME; HUMAN; INFECTION; MAJOR CLINICAL STUDY; MONOTHERAPY; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROTOXICITY; NEUTROPENIA; OVERALL SURVIVAL; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA; TREATMENT OUTCOME; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; ANTHRACYCLINES; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CARCINOMA; CHEMOTHERAPY, ADJUVANT; DEOXYCYTIDINE; DRUG RESISTANCE, NEOPLASM; FEMALE; FLUOROURACIL; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; SALVAGE THERAPY; TAXOIDS; VINBLASTINE;

EID: 84860432166     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdr405     Document Type: Article

References (27)

1. Jemal A, Siegel R, Xu J et al. Cancer statistics, 2010. CA Cancer J Clin 2010; 60: 277-300.
2. Hortobagyi GN, de la Garza SJ, Pritchard K et al. The global breast cancer burden: variations in epidemiology and survival. Clin Breast Cancer 2005; 6: 391-401.
3. Chia SK, Speers CH, D'yachkova Y et al. The impact of new chemotherapeutic and hormone agents on survival in a population-based cohort of women with metastatic breast cancer. Cancer 2007; 110: 973-979.
4. Amar S, Roy V, Perez EA. Treatment of metastatic breast cancer: looking towards the future. Breast Cancer Res Treat 2009; 114: 413-422.
5. Pronzato P, Rondini M. First line chemotherapy of metastatic breast cancer. Ann Oncol 2006; 17 (Suppl 5): v165-v168.
6. Fossati R, Confalonieri C, Torri V et al. Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women. J Clin Oncol 1998; 16: 3439-3460.
7. Ghersi D, Wilcken N, Simes J et al. Taxane containing regimens for metastatic breast cancer. Cochrane Database Syst Rev 2003; CD003366.
8. Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005; 365: 1687-1717.
9. De Laurentiis M, Cancello G, D'Agostino D et al. Taxane-based combinations as adjuvant chemotherapy of early breast cancer: a meta-analysis of randomized trials. J Clin Oncol 2008; 26: 44-53.
10. Moreno-Aspitia A, Perez EA. Anthracycline- and/or taxane-resistant breast cancer: results of a literature review to determine the clinical challenges and current treatment trends. Clin Ther 2009; 31: 1619-1640.
11. Rivera E. Management of metastatic breast cancer: monotherapy options for patients resistant to anthracyclines and taxanes. Am J Clin Oncol 2010; 33: 176-185.
12. Blum JL, Jones SE, Buzdar AU et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1999; 17: 485-493.
13. Blum JL, Dieras V, Lo Russo PM et al. Multicenter, phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer 2001; 92: 1759-1768.
14. Fumoleau P, Largillier R, Clippe C et al. Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer 2004; 40: 536-542.
15. Reichardt P, Von MG, Thuss-Patience PC et al. Multicenter phase II study of oral capecitabine (Xeloda(")) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy. Ann Oncol 2003; 14: 1227-1233.
16. Stathopoulos GP, Rigatos SK, Pergantas N et al. Phase II trial of biweekly administration of vinorelbine and gemcitabine in pretreated advanced breast cancer. J Clin Oncol 2002; 20: 37-41.
17. Therasse P, Arbuck SG, Eisenhauer EA et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92: 205-216.
18. Oken MM, Creech RH, Tormey DC et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5: 649-655.
19. ICH Efficacy Guidelines. E6(R1). Good Clinical Practice: Consolidated Guideline. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf (10 April 2010, date last accessed).
20. Cancer Therapy Evaluation Program. Common Toxicity Criteria. Version 2.0. DCTD, NCI, NIH, DHHS 1998.; http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcmanual_v4_10-4-99.pdf.
21. Smith TJ, Khatcheressian J, Lyman GH et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol 2006; 24: 3187-3205.
22. Bokemeyer C, Aapro MS, Courdi A et al. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer 2007; 43: 258-270.
23. Collet D. Modelling Survival Data in Medical Research, 3rd edition. Oxford, UK: Blackwell Scientific 1994.
24. Martin M, Ruiz A, Munoz M et al. Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish Breast Cancer Research Group (GEICAM) trial. Lancet Oncol 2007; 8: 219-225.
25. Sparano JA, Vrdoljak E, Rixe O et al. Randomized phase III trial of ixabepilone plus capecitabine versus capecitabine in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol 2010; 28: 3256-3263.
26. Thomas ES, Gomez HL, Li RK et al. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 2007; 25: 5210-5217.
27. Miller KD, Chap LI, Holmes FA et al. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol 2005; 23: 792-799.